Specific requirements for hip-joint replacement implants ISO 21535
Normative References
ISO 21535: Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint implants
ISO 7206-1: Implants for surgery – Partial and total hip joint prostheses – Part 1: Classification and designation of dimensions
ISO 7206-2: Implants for surgery – Partial and total hip joint prostheses – Part 2: Articulating surfaces
made of metallic, ceramic and plastics materials
ISO 7206-4: Implants for surgery – Partial and total hip joint prostheses – Part 4: Determination of
endurance properties of stemmed femoral components
ISO 7206-6: Implants for surgery – Partial and total hip joint prostheses – Part 6: Determination of
endurance properties of head and neck region of stemmed femoral components
ISO 7206-10: Implants for surgery – Partial and total hip joint prostheses – Part 10: Determination of
resistance to static load of modular femoral heads
ISO 14630: Non-active surgical implants - General requirements
ISO 21534: Non-active surgical implants – Joint replacement implants – Particular requirements
The normative standard provides specific requirements for hip joint replacement implants. Amongst others, test services evaluating the dimensional properties (such as UHMWPE insert thickness, range of motion analysis, articular surface roughness and sphericity) and physical properties (such as wear, femoral stem fatigue and pull-off characteristics of heads) are provided by EndoLab®.
This standard is currently under revision and will provide an updated summary of the tests needed for safety evaluation of hip implants. Additional performance criteria will be provided.
